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Pharmacy Laws
| Question | Answer |
|---|---|
| THE KEFAUVER-HARRIS AMENDMENTS OF 1962 | • Amendment to the Food, Drug, and Cosmetic Act stating that drug products, both prescription and non-prescription, must be effective and safe. • Response to the thalidomide tragedy • Informed consent was required for trial patients. |
| CONTROLLED SUBSTANCE ACT (THE COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL ACT OF 1970 ) | • Established drugs with potential abuse or addiction to place in 5 schedules based on their potential for abuse. |
| Controlled Substance Schedules I -II | • Schedule I have highest abuse and no acceptable medical use • Schedule II have high potential for abuse including opiates and opium derivatives, stimulants, and depressants. The prescriptions have no refills available and must have a written script. |
| Controlled Substances Schedules III | •III have moderate potential for abuse. The prescriptions can have 5 refills and are good for 6 months. |
| Controlled Substances Schedule V | Schedule V have lowest abuse potential. These are generally antitussives and antidiarrheals. |
| Controlled Substances Schedule IV | IV have low potential for abuse and contain long-acting barbiturates, hypnotics, and tranquilizers. The prescriptions are good for 6 months and may have 5 refills. |
| DEA 222 | Order or return |
| DEA 106 | Lost or stolen |
| DEA 41 | Outdated or damaged |
| The Poison Prevention Packaging Act of 1970 | • Created standards for child-resistant packaging • Most OTC and Legend drugs must be packaged in child-resistant containers (cannot be opened by 80% under 5 but can be opened by 90% of adults) |
| Exceptions to PPA | o Prescriber writes “no child-resistant cap on RX o Dispensed in nursing home or hospital o If patient requests o Nitroglycerin, stool softeners, dietary supplements, unit dose medications |
| The Occupational Safety and Health Act 1970 | • OSHA administers the act as a part of the Department of Labor. • OSHA’s mission is to ensure safety and a health environment within the workplace • 1986 OSHA began MSDS (now known as MSDS) • OSHA July 1992 Blood-Borne Pathogens Standard (AIDS) |
| The Drug Listing Act of 1972 | • Each new drug is assigned a unique and permanent product code known as National Drug Code (NDC) • FDA maintains a database of drugs |
| NDC Number | First set of numbers is Manufacturer or distributor Second set of numbers is Drug formulation Third set of numbers is the size and type of packaging |
| The Medical Device Amendments of 1976 | • Requires manufacturers to register and list their products, follow good practices during making those products, and report failures (Class I,II,II) |
| The Orphan Drug Act of 1983 | • New drugs cost a lot to develop so was not beneficial for diseases that affect only a small number of persons • Drugs that treat fewer than 200,000 people in the US • Offers federal incentives to development and market these drugs |
| The Drug Price Competition and Patent Term Restoration Act of 1984 | • Abbreviated applications for new drugs and an accelerated procedure for approval of generics • Abbreviated new drug application (ANDA) has the manufacturer demonstrate bioequivalence to a product instead of having to due preclinical trials |
| The Prescription Drug Marketing Act of 1987 | • Deals with the safety and competition issues raised by secondary market for drugs • Prevents reimportation of a drug into the US by anyone but the manufacturer • Prohibits the sale or trading of drug samples |
| The Anabolic Steroids Control Act of 1990 | Placed anabolic steroids under the regulatory provisions of the CSA • These products include testosterone, estrogen, progestins, and corticosteroids which promote muscle growth |
| The Omnibus Budget Reconciliation Act of 1990 | • Also known as OBRA ‘90 • Requires pharmacists to offer to discuss information about new and refill prescriptions with Medicaid patients to receive reimbursement and do a DUE |
| The Dietary Supplement Health and Education Act of 1994 DSHEA | • Clarify the regulatory framework applicable to nutritional supplements and to create specific labeling requirements • Burden of proof on FDA to prove a substance is harmful |
| The Health Insurance Portability and Accountability Act of 1996 | • Electronic coding systems • Unique identifiers when organizations deal with each other • Security and Electronic Signature standard: Safeguards • Privacy and Confidentiality Standards: |
| The Drug Addiction Treatment Act of 2000 | • Allows physicians to RX to people addicted to opioids as part of maintenance or detoxification treatments. • Patient must be in a treatment program with additional support services • These are noted by DEA numbers with the letter X in the front |
| The Medicare Prescriptions Drug Improvement, and Modernization Act of 2003 This act is also known as Medicare Modernization Act or MMA | • Designed to provide seniors and disabled individuals with a prescription drug benefit, additional choices (Medicare Advantage) and more Medicare benefits • Established Medicare Part D which is a voluntary prescription drug benefit program |
| The Combat Methamphetamine Epidemic Act of 2005 | • Designed to stop illegal use of drugs such as methamphetamine, crack and others • The customer must provide identification and signature allowing government to track their purchase and meds located behind the counter |
| Amount of Sudafed federally allowed to be dispensed | • Only 9 g per month per person federally is allowed to be sold with a 3.6 g daily requirement (no more than 146 tablets of 30 g tablets. |
| Accutane iPLEDGE Program of 2006 | This program was designed to mandate distribution in the United States for the drug known as isotretinoin (commonly sold under the trade name Accutane). This drug is used to treat severe cystic acne when other methods have not been successful. |
| The Patient Protection and Affordable Care Act of 2010 (Obama Care) | • Its goal is to increase the quality and affordability of health insurance, lower the uninsured rate by expanding public and private insurance coverage, and reduce costs of health care for individuals and the government. |
| Synthetic Drug Abuse Prevention Act of 2012 | • This act banned compounds commonly found in synthetic marijuana sold as “K2” or “Spice,” synthetic stimulants such as bath salts, and hallucinogens by placing them under Schedule I of the CSA |
| Drug Quality and Security Act of 2013 | • This act created FDA oversight for large-volume compounding operations and created track-and-trace requirements for drug products that will take effect over the next 10 years. |
| Comprehensive Addiction and Recovery Act of 2016 | This act improved access to overdose treatment; authorized grants to states to implement strategies for pharmacists to dispense naloxone |
| FDA | The agency oversees all domestic and imported food, bottled water. It is also responsible for cosmetics, medicines, medical devices, radiation-emitting products, and even the feed and drugs used for farm animals. |
| CDC | The CDC is a federal agency that provides facilities and services for the investigation, identification, prevention, and control of disease |
| DEA | The DEA oversees controlled substances, including the investigation and prosecution of individuals who grow or manufacture substances for illegal distribution. |
| Drug Recalls | Assigned by FDA: Class I: adverse reactions or death. Class II: may cause temporary or medically reversible adverse health hazards. Class III: not likely to cause adverse health hazards. |
Created by:
melissa.burgess